Home / 510(k) Clearances / K141874

510(k) K141874

URISCAN OPTIMA by Yd Diagnostics Corp. — Product Code KQO

K141874 is an FDA 510(k) premarket notification submitted by Yd Diagnostics Corp. for the device "URISCAN OPTIMA". The FDA issued a decision of Substantially Equivalent on May 28, 2015. The device falls under product code KQO (Automated Urinalysis System), a Class I device regulated under 21 CFR 862.2900. Yd Diagnostics Corp. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 28, 2015
Date Received
July 11, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Automated Urinalysis System
Device Class
Class I
Regulation Number
862.2900
Review Panel
CH
Submission Type

Other clearances by Yd Diagnostics Corp.

  • K060953 — OCCULTECH FECAL OCCULT BLOOD RAPID TEST (September 18, 2006)
  • K050801 — URISCAN OPTIMA II URINE ANALYZER (April 20, 2005)
  • K023027 — PREG-Q EARLY PREGNANCY TEST (December 16, 2002)

Other clearances for product code KQO

  • K142543 — Mission U120 Ultra Urine Analyzer, Mission Liquid Urine Controls, Mission Liquid (May 11, 2015)
  • K140717 — CLINITEK NOVUS; AUTOMATED URINE CHEMISTRY ANALYZER, 10 URINALYSIS CASSETTE, CALI (November 17, 2014)
  • K121456 — AUTION HYBRID AU-4050 FULLY AUTOMATED INTEGRATED URINE ANALYZER SYSTEM; URIFLET (February 1, 2013)
  • K102188 — CYBOW READER, MODELS 300 & 720 (August 9, 2011)
  • K101852 — CHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM, STRIPS AND CALCHEK KIT (March 23, 2011)
  • K091472 — URITEST 50 AND URITEST 500 URINE ANALYZER (April 27, 2010)
  • K093555 — COBAS U411 TEST SYSTEM (April 2, 2010)
  • K093098 — AUTION MAX MODEL AX-4030 URINALYSIS SYSTEM (December 23, 2009)
  • K070929 — ACON U120 URINE ANALYZER, MODEL U111-101 (July 30, 2007)
  • K053253 — HEMOCUE ALBUMIN 201 ANALYZING SYSTEM (February 17, 2006)

FDA data resources